RecruitingPhase 1NCT05504707

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer

Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

30 participants

Start Date

Aug 26, 2022

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer HER2-negative Breast Cancer

Summary

The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (DecipHER) is testing a chemotherapy regimen before surgery (neoadjuvant) in patients with early-stage triple-negative or hormone receptor-low breast cancer that does not have the HER2 protein. The goal is to shrink the tumor before surgery to improve outcomes. **You may be eligible if...** - You are 18 or older with HER2-negative breast cancer - Your tumor is hormone receptor-negative or "low positive" - Your cancer is stage T1c with lymph node involvement, or stage T2–T4 with or without node involvement - Your overall health is good (ECOG 0 or 1) and organ function is adequate **You may NOT be eligible if...** - Your cancer is HER2-positive - You have metastatic (stage IV) disease - Your organ function does not meet the required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALHER2 - primed Dendritic cells

Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 - primed Dendritic cells dose 30-50 million Dose level 3: HER2 - primed Dendritic cells dose 80-100 million

BIOLOGICALHER3 - primed Dendritic cells

Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 - primed Dendritic cells dose 30-50 million Dose level 3: HER3 - primed Dendritic cells dose 80-100 million

Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05504707

Related Trials

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

NCT0500540346 locations

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

NCT0711504313 locations

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521192 locations

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

NCT05633654350 locations

MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors

NCT050767602 locations